CoRoent 7151055Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887517231703), received between Apr 20, 2017 and Mar 3, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Failure to Osseointegrate” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2021Migration; Migration

  ON A UNKNOWN DATE IN (B)(6) 2020 A FEMALE PATIENT UNDERWENT A EXTREME LATERAL INTERBODY FUSION PROCEDURE AT L4-L5. THE PATIENT BEGAN TO EXPERIENCE PAIN POST-OP AND ON A UNKNOWN DATE IT WAS DISCOVERED THAT THE IMPLANTED CAGE HAD MIGRATED ANTERIORLY. ON (B)(6) 2020 A REVISION OCCURRED WHERE THE MIGRATED IMPLANT WAS REMOVED AND REPOSITIONED. IT WAS REPORTED THE PATIENTS PAIN HAS IMPROVED POST REVISION.

  Patient problems: Pain

  MAUDE report 11407540 ↗
• MalfunctionApr 20, 2017Migration or Expulsion of Device; Failure to Osseointegrate; Migration or Expulsion of Device; Failure to Osseointegrate

  PATIENT UNDERWENT A LATERAL INTERBODY FUSION PROCEDURE AT L3-4 ON (B)(6) 2016. A PEEK INTERBODY CAGE WAS IMPLANTED WITH ADDITIONAL FIXATION HARDWARE. IN ADDITION, A BONE GRAFT WAS PLACED INSIDE THE CAGE AND IN THE POSTERIOR LATERAL GUTTERS. ONE YEAR AFTER INDEX SURGERY, RADIOGRAPHS INDICATED L3-4 HAD NOT FUSED AND THE CAGE MIGRATED ANTERIORLY. THE PATIENT REPORTED SEVERE PAIN. NO INJURY WAS REPORTED.

  Patient problems: Pain

  MAUDE report 6509947 ↗